ES2326321T5 - Prechargeable intraocular implant injector - Google Patents

Abstract

An IOL retainer (40) adapted to releasably hold an IOL (30) in an unstressed state, characterized in that said retainer is adapted to be removably attached to an IOL injector (12) while maintaining said IOL in said state unstressed, whereby removal of the retainer from the IOL injector results in the IOL being disengaged from the retainer and placed in the injector ready for administration through and into an eye.

Description

Prechargeable intraocular implant injector.

Background of the invention

The present invention relates to ophthalmic surgical devices and loading methods. More specifically, the present invention relates to a device for inserting an intraocular lens (IOL) into an eye and to a method where the IOL can be conveniently preloaded and packaged together with the injector device.

IOLs are artificial lenses used to replace the natural lens of the eye, when the natural lens has cataracts or another disease. IOLs are also sometimes implanted in one eye to correct refractive errors of the eye, in which case the natural lens can remain in the eye in conjunction with the implanted IOL. The IOL can be placed in the posterior chamber or in the anterior chamber of the eye. IOLs come in various configurations and materials. Some common types of IOLs include so-called open loop haptics that include the type of three pieces that have an optic and two haptics attached to the optic and extend from it; the type of a piece where optics and haptics are integrally formed (for example, machining optics and haptics together from a single block of material); and also the closed loop haptic IOLs. Another style of IOL is called the type of plate haptic where the haptics are configured as a flat plate that extends from opposite sides of the optic. The IOL can be made of various materials or combination of materials such as PMMA, silicone, hydrogels and silicone hydrogels, etc.

Several instruments and methods for implanting IOL in the eye are known. In one method, the surgeon simply uses a surgical forceps that has opposite blades that are used to grab the IOL and insert it through the incision in the eye. Although this method is still in practice today, more and more surgeons are using more sophisticated IOL insertion devices that offer advantages such as giving the surgeon greater control when inserting the IOL into the eye. Recently, IOL insertion devices with small diameter insertion tips have been developed that allow a much smaller incision to be made in the cornea than is possible using forceps only. Smaller incisions (for example, less than about 3 mm) are preferred over larger incisions (for example, approximately 3.2 to 5+ mm) since smaller incisions are attributed a reduced time of post-operative healing and fewer complications, such as induced astigmatism.

Since IOLs are very small and delicate items to manufacture, care must be taken in handling them. To fit the IOL through the smaller incisions, they must be folded and / or compressed before entering the eye where they will assume their original unfolded / decompressed form. Therefore, the IOL insertion device must be designed in such a way that it allows the easy passage of the IOL through the device and into the eye, but without damaging the delicate IOL at any time. If the IOL was damaged during placement in the eye, the surgeon would most likely have to remove the damaged IOL from the eye and replace it with a new IOL, a highly undesirable surgical result.

Thus, as explained above, the IOL insertion device must be designed to allow easy passage of the IOL through it. It is equally important that the IOL be ejected from the tip of the IOL insertion device and into the eye in predictable orientation and shape. If the IOL is ejected from the tip too quickly or in the wrong orientation, the surgeon should manipulate the IOL more in the eye, which could result in trauma to the surrounding tissues of the eye. Therefore, it is highly desirable to have an insertion device that allows the exact loading of the IOL into the insertion device and that passes and expels the IOL from the tip of the insertion device and to the eye in a controlled, predictable and repeatable manner.

To ensure controlled expulsion of the IOL through the tip of the IOL insertion device, the IOL must first be loaded into the IOL insertion device. Therefore, the loading of the IOL into the insertion device is a precise and very important step in the process. Incorrect loading of an IOL into the insertion device is often cited as the reason for a failed IOL placement sequence. Many IOL injector devices on the market today require loading the IOL into the injector at the time of surgery performed by the assistant nurse and / or the surgeon. Due to the delicate nature of the IOL, there is a risk that the nurse and / or the surgeon accidentally damage the IOL and / or incorrectly load the IOL in the injector device, resulting in a failed implant. Therefore, direct handling and / or loading of the IOL in the injector by the nurse and / or the surgeon is undesirable.

In a typical IOL insertion device, the IOL insertion device uses a piston that has a tip that engages the IOL (which has been previously loaded and compressed into the lumen of the insertion device) so that it passes through the lumen of the insertion device. The IOL thus connects with the piston tip as well as the lumen of the insertion device. The lumen is typically sized with a narrowing toward its open tip in order to further compress the IOL as it advances through the lumen. The lumen tip is sized for introduction through the surgical incision which, as indicated above, is currently preferred to be in the range of less than 3 mm. Thus, a lumen of the insertion device will typically have larger dimensions in the loading area of the IOL and will gradually decrease in diameter at the tip of the lumen where the IOL is ejected into the eye. It will be appreciated that the compressed diameter of the IOL at the tip of the lumen is the same as the inside diameter of the tip of the lumen, preferably less than 3 mm, as indicated above. Each of these component interfaces are dynamic in the sense that the forces acting between the interface components (i.e., the IOL, the piston tip and the lumen of the insertion device) will vary when the IOL is pushed through of the lumen. Therefore, the control of these dynamic forces is of utmost importance or otherwise the IOL can be damaged during placement due to excessive compression forces acting on it. For example, when the IOL is advanced by the piston through a lumen of increasing diameter, the IOL is compressed while at the same time increasing the forces necessary to push the IOL through the lumen. This may result in excessive force between the piston tip and the IOL, resulting in possible damage to the IOL and / or uncontrolled release of the IOL from the lumen tip. In addition, the force of the piston tip can cause the IOL to twist and / or turn when it travels through the insertion device, so that the force between the IOL and the piston tip and / or the lumen of the device Insertion can increase uncontrollably to the point of damaging the IOL. US 2002/082 609 describes an IOL injector device with a retainer.

Several insertion devices have been proposed that attempt to solve these problems, but there is still a need for an IOL insertion device that eliminates the need for direct management of the IOL by the nurse and / or surgeon and generally simplifies the operation of the device. IOL injector and the IOL dispensing process.

Summary of the Invention

In a first aspect of the invention, an injector device is provided having an IOL preloaded therein and where the injector device and the IOL are packaged together as a single unit. An IOL retainer loosely holds the IOL in a "preloaded" position in the unstressed state; that is, in a state where no effort is substantially made on its optical portion. In this embodiment, the device is in the pre-loaded position from the time of final assembly and packaging at the manufacturing site, during shipment and actual use of the device by a surgeon. The storage position is thus the position of the IOL while being retained by the IOL retainer.

The injector body includes an IOP opening and loading bay where the retainer removably attaches to the body of the insertion device with the IOL captured by the retainer and held by it in the preloaded position. The IOL retainer includes elements to loosely support the optics of the IOL. In IOLs that include one or more haptics attached to the periphery of the optic and that extend from it, the IOL retainer includes other elements to loosely support the haptic (s) as well as the optics. In the preferred embodiment, the haptics are supported by the IOL retainer in the preloaded position at the correct vault angle (i.e., the angle at which they normally extend from the periphery of the optic).

In manufacturing, the IOL is detachably coupled to the IOL retainer with the optics and haptics maintained by IOL support elements of the retainer. The retainer is then removably attached to the body of the insertion device in its opening and loading bay. A separation element extends between the optic of the IOL and the body of the retainer to prevent the IOL from remaining coupled to the retainer when the retainer is removed from the body of the insertion device. This will be explained more fully later.

Once the device is ready for use, the package is opened in a sterile place in the operating room and viscoelastic is applied, as necessary, around the IOL and / or the injector body according to the surgeon's wishes and / or the user guidelines provided with the package. The IOL retainer is then separated from the injector device. This can be done by manually separating the IOL retainer from the injector device. In this regard, a traction element with the finger or other element is provided in the IOL retainer body to facilitate manual decoupling of the injector body retainer.

As indicated above, a separation element is disposed between the retainer and the IOL optic. As such, when the retainer moves away from the injector body, the optic of the IOL presses against the separation element thereby preventing the IOL from remaining with the retainer when the retainer disengages from the injector body. Thus, the movement of the retainer when it is disengaged from the injector device causes the IOP optic to press against the separation element and subsequently be released from the optic support element of the IOL retainer, in addition to the haptic (s) ) of IOLs are released from the haptic support elements of the IOL retainer. Once completely released from the retainer, the IOL is in the “charged” position inside the injector device and ready to compress and be placed through a small incision in one eye.

In an alternative embodiment of the invention, the retainer and the IOL attached thereto can be packaged separately from the injector device, whereby the retainer and IOL are attached to the injector body at the time of surgery rather than at the time of the manufacturing.

The injector includes means for compressing, rolling or otherwise pushing the IOL to a smaller cross section for dispensing through the injector. In a preferred embodiment of the invention, the injector device includes a compressor that extends laterally from the IOL loading bay of the injector body. The compressor can move between fully open and fully closed positions, and is in the open position when the injector device is packaged and the IOL is in the storage position. Once the package has been opened and the IOL retainer has been decoupled from the injector device, the compressor moves to the closed position that compresses the IOL optics. A piston advances at the proximal end of the injector device causing the tip of the piston to engage the proximal end of the compressed optics. When the piston is advanced further, the IOL is pushed through the distal end of the injector body and ejected into the eye as intended. In another preferred embodiment of the invention, a haptic traction device is disposed at the distal end of the injector body that includes a finger to engage the front haptic of the IOL. Before the piston is fully advanced, the haptic traction device is manually removed from the distal tip of the injector device causing its finger portion to pull the front haptic and straighten it into the distal tip of the injector device. This eliminates the possibility that the front haptic gets stuck inside the injector body when the piston is fully advanced through the injector device.

The relative placement of the IOL retainer, the IOL and the injector device is such that, by uncoupling the IOL retainer from the injector device (and thus releasing the IOL from the retainer), the IOL is preferably placed within the injector device. The IOL is thus placed in a particular orientation within the injector device relative to the piston tip and the

haptic traction device. This "IOL release position" results in the front haptic engaging

the haptic traction device correctly, and that the rear haptic extends backwards from the piston tip so that, at the advance of the piston, the piston tip engages the IOP optics as intended without obstruction

or rear haptic jam.

Brief description of the drawings

Figure 1 is a perspective view of an embodiment of the invention depicting the device with the retainer and IOL coupled to the injector body in the storage position.

Figure 2A is a partial plan view of the injector body representing its IOL loading bay portion.

Figure 2B is a partial sectional side elevation view showing the rear haptic resident in a recess located next to the piston tip that engages the IOP optic.

Figure 3A is an enlarged perspective view of the loading bay area of the injector device of Figure 1.

Figure 3B is a cross-sectional view taken through the IOL loading bay of the injector device with the compressor drawer in the fully open position.

Figure 3C is a cross-sectional view taken along line 3C-3C of Figure 3A.

Figure 3D is the view of Figure 3C with the compressor drawer shown in the fully closed position. Figure 3E is a cross-sectional view taken through the IOL loading bay area and depicting an alternative embodiment of the separation finger component of the injection device.

Figure 4 is the view of Figure 1 depicting the removal of the IOL retainer from the injector body and the compressor drawer in the fully closed position.

Figures 5A-5C are perspective, top and side views of the IOL retainer with an IOL detachably maintained by it.

Figure 6 is a perspective view showing the injector device in the process of expelling an IOL from it. Figure 7 is the view of Figure 6 depicting the IOL completely ejected from the injector device.

Figures 8 and 9 are perspective and plan views of the compressor drawer and separating finger component of the injector device, respectively.

Figure 10 is a side elevational view of the partially preloaded embodiment of the invention depicting the retainer and IOL coupled together and sealed in a single package.

Figure 11 is a plan view of the preloaded embodiment of the invention depicting the injector body 12, the retainer 40 and the IOL 30 coupled together and sealed in a single package.

Figure 12 is a cross-sectional view of the package of Figure 11 taken generally along line 12-12 in Figure 11.

Figure 13A is a perspective view of another embodiment of the lens retainer representing an IOL coupled thereto in the intended manner.

Figure 13B is a top plan view of Figure 13A.

Figure 13C is a side elevation view thereof.

Figure 13D is a perspective view of the retainer and IOL in spaced relationship to a retainer cover.

Figure 13E is a perspective view showing the retainer and cover coupled together.

Figure 13F is a bottom plan view of the retainer cover.

Figure 13G is a plan view of a representative IOL for use with the present invention.

Figure 14 is a plan view of another embodiment of the injector device with the compressor drawer shown in the fully open position relative to the injector body.

Figure 15A is a perspective view of the injector device of Figure 14.

Figure 15B is a perspective view of the injector device of Figures 14 and 15A depicting the compressor drawer in the partially closed position relative to the injector body.

Figure 15C is a front elevation view of Figure 15B.

Figure 15D is a top plan view of Figures 15B and 15C.

Figure 15E is a side elevational view in cross section of Figure 15D depicting the relative placement of the retaining fingers of the retainer, the IOL, the piston tip and the haptic traction device when the compressor drawer is in partially closed position.

Figure 15F is a perspective view of the injector device of Figures 14-15E depicting the compressor drawer in the partially closed position and the retainer being removed from the injector device, the IOL remaining with the injector device. Figure 16A is a top plan view of the injector device of Figures 14-15E after removal of the retainer and the compressor drawer moved to the fully closed position.

Figure 16B is a perspective view of the compressor drawer of the embodiment of Figures 14-16A.

Figure 16C is a cross-sectional view showing the IOL when it engages the through hole 150a of the optical separation element 150 when the retainer has been removed from the injector device.

Figure 17 is a perspective view of another embodiment of the haptic traction component device. And Figure 18 is a perspective view of another embodiment of the piston component.

Detailed description

With reference now to the drawing, a preferred embodiment of the invention denoted by reference number 10 is shown in the figures. In a first broad aspect, the invention includes a preloaded injector device for injecting an IOL into an eye. The term "preloaded" in the sense used herein means that the injector body 12 is packaged together with an IOL where the IOL 30 is held by a retainer 40 in a storage position in the injector body (see also the Figures 11 and 12). In an alternative embodiment of the invention, the injector device is "partially preloaded" which means that IOL 30 and retainer 40 are coupled and packaged together, but not yet coupled to injector body 12 (see also Figure 10). In this alternative embodiment, the doctor or nurse attaches the retainer and IOL to the injector body at the time of surgery.

The injector body 12 includes a longitudinal lumen 14 extending from the proximal end 16 to its distal end 18. The lumen can assume any desired cross-sectional shape, although circular or oval shapes are preferred. The lumen 14 tapers inward towards the distal tip 18 so that the IOL 30 is gradually compressed to a very small cross section when it exits the tip 18a. The tip 18a may include one or more slits 18a 'that extend longitudinally to allow a gradual expansion of the IOL 30 when it leaves the tip 18a inside the eye. This prevents uncontrolled expansion of the IOL in the eye that could potentially damage the delicate surrounding tissues of the eye. The proximal end 16 may include a finger holding tab 17 preferably configured with a straight edge 17a as shown to leave the device 10 on a flat surface. A piston 20 having distal and proximal lengths 20a, 20b, respectively, and a distal piston tip 22 (see Figure 2) and the next pressure element with the thumb 24 telescopes into the lumen 14 to engage and push the IOL 30 through lumen 14 and outside the distal tip 18a. The IOP dispensing sequence will be explained in more detail later. It is understood that the general configuration of the injector body 12 may vary with respect to that here represented and described. It is also understood that the components of the injector device can be made of any suitable material (for example, polypropylene) and can be completely or partially opaque, transparent or translucent to better see the IOL within the injector device and the IOP dispensing sequence. .

The injector body 12 further includes a hole 26 that opens to the lumen 14. The hole 26 is configured to receive an IOL 30 to dispense the IOL through the distal tip 18a. The explanation will now refer to the preloaded position of the IOL followed by the explanation of the loading and dispensing sequence of the IOL.

The preloaded condition of the IOL

In a preferred embodiment, the device 10 includes an IOL retainer 40 used to detachably hold an IOL 30 in the preloaded position relative to the injector body 12. The IOL retainer 40, with the IOL 30 detachably held therein, is attached extractable to the injector body 14 in the hole 26. As best seen in Figures 5A-C, the IOL retainer 40 includes one or more, but preferably two optical support elements 42a and 42b, each having a lip 42a ', 42b' or other element to loosely support the optic of the IOL 31 at its periphery 31a. Alternatively or in addition to the optical support elements, one or more, but preferably two haptic support elements 44a and 44b are arranged in the retainer 40, each including a finger 44a ', 44b' or other element to support detachably one or more, but preferably two haptics 33a and 33b that join the optic 31 and extend from it. In this regard, it is understood that the IOL configuration shown and described herein is for explanatory purposes only, and that the present invention is not to be limited thereto. The invention can be easily adapted to IOLs of any configuration and type (e.g., IOLs with plate, open or closed loop haptics, anterior chamber IOLs, posterior chamber IOLs, accommodative IOLs (including single and double lens types), etc). The general configuration of the IOL retainer 40 can likewise be varied so that it is cooperatively configured and loosely maintaining the particular IOL configuration that is used with the device. In all embodiments, the retainer 40 holds at least the optic of the IOL 31 in the unstressed state. It is also preferable that the retainer 40 keep the IOP haptics at the correct vault angle (i.e., the angle at which they normally extend from the IO periphery optics). It is even more preferable that the haptic support elements maintain loop haptics at the correct angle of curvature. In Figures 5A-C it is seen that the haptic support elements retain the haptics along their curved outer edges. This ensures that the curvature of the haptic, which is designed and established when manufacturing the haptics, does not increase or leave the specification during storage of the IOL and the retainer.

In manufacturing, the IOL 30 is detachably fixed to the IOL retainer 40. This can be done by engaging the optics of the IOL 31 with the IOL support elements 42a, 42b, and / or by engaging the haptics 33a, 33b with the elements. of haptic support 44a, 44b, respectively. For the purpose of description, the haptic 33a will be called the front haptic since it is located distally in the injector body, while the haptic 33b will be called the rear haptic since it is located shortly in the injector body (see Figure 2) .

The loose connection of the IOL 30 to the IOL retainer 40 can be done by an operator using a pair of pliers, for example, although other methods can be used at will, including automated or semi-automated means.

As explained above, in the preloaded embodiment of the invention, retainer 40 and IOL 30 are coupled to injector body 12 when manufactured, and sealed and sterilized in the same package for delivery to the surgeon. For example, as seen in Figures 11 and 12, a thermoformed plastic package 11 is provided including a cavity 11a in the general form of the injector device 10 for packaging the device 10 together with the retainer 40 and the IOL 30 coupled to he. A flexible cover sheet 11b is sealed around the perimeter of the cavity 11a to seal the package. At the time of performing the surgery, the cover 11b is removed to access the device 10.

Thus, once the IOL 30 is detachably fixed to the retainer 40 as described above, the IOL retainer 40 is extractablely attached to the injector body in the hole 26. This can be done by suitable mechanical fasteners that will removably connect the retainer 40 to the injector body 12; Examples include friction fit, jump fit, interference fit, cooperating tabs and seals, seals, etc. As seen in Figures 1 and 3A, the retainer 40 is held in position in the hole 26 by a friction fit between the surfaces defining the hole 26 and the opposite outer wall surfaces 41a and 41b of the retainer 40. It will be seen that when the retainer 40 and the IOL 30 are coupled together and attached to the injector body 12, the optic of the IOL 31 is not subjected to stress and also does not contact any part of the injector body 12. This ensures that the delicate optic 31 of the IOL is not damaged during storage.

When the retainer 40 and the IOL 30 are coupled together and attached to the injector body 12, a separating finger 50 is located between the optics of the IOL 31 and the central wall surface 46 of the retainer 40, as best seen in the Figures 1, 3A and 3C. The primary function of the separation finger 50 is to prevent the IOL 30 from rising with the retainer 40 when the retainer separates from the injector body (this operation will be described below). In a preferred embodiment of the invention, the separating finger 50 is attached to the compressor drawer 60 that can be moved relative to the injector body 12 between a fully open position as seen in Figure 3B, an intermediate position represented in the Figures 1, 3A, 3C and 3E, and the fully closed position shown in Figures 3D, 4, 6 and 7. The separating finger 50 is located between the optic 31 of the IOL and the central wall surface 46 when The compressor 60 is in the intermediate position, which is also the preloaded position of the injector device as described herein. When the compressor drawer 60 is moved to the fully closed position, the separation finger 50 moves with it and rests in a position laterally adjacent to the injector body 12 as seen in Figures 3D, 4, 6 and 7.

In an alternative embodiment, the separating finger 50 may be formed separately from the compressor drawer 60 if desired. An example is shown in Figure 3E where the separating finger 50 has been formed with a clip 50a that can be mounted on the injector body 12 opposite and separately from the compressor drawer 60. In this embodiment, the separating finger 50 it is removed from the injector body 12 after removal of the retainer 40 and before closing the drawer of the compressor 60. Other embodiments will be apparent to those skilled in the art to separate the IOL 30 from the retainer 40 when the retainer is removed from the body of injector 12 and thus fall within the scope of this invention.

With reference to Figures 1, 2, 4, 6 and 7, it is seen that the piston 20 includes distal and proximal piston shaft lengths 20a, 20b, respectively, with a piston tip 22 at its distal end and an element of Press with your thumb 24 at its near end to manually operate the injector device. The piston tip 22 is configured to engage the optic of the IOL 31 at its periphery 31a when the piston 20 is advanced towards the distal tip 18a of the injector body 12. It is very important that the piston tip 22 does not damage the optics of the IOL 31. The piston tip 22 is designed in order to avoid damaging the optic of the IOL 31. In the preferred embodiment, the tip forks to first and second tip portions 22a and 22b, whereby the The optic periphery of the IOL 31a engages between tip portions 22a, 22b as seen in Figure 2B. It is understood that other piston tip designs can be used at will with the present invention. It is also preferred that the piston shaft be rotationally fixed within lumen 14 to avoid unexpected rotation of the shaft (and hence the tip 22) with lumen 14. The piston shaft can be set rotationally forming the proximal length 20b of the shaft and lumen 14 of non-circular cross section.

In an especially advantageous embodiment, the proximal length 20b of the piston shaft is provided with one or more elongate fingers 23a, 23b forming springs that are pushed radially outward against the inner wall of lumen 14 (see Figures 1 and 6). The purpose of the spring fingers 23a, 23b is to perform the proper centering of the piston shaft and the tip, as well as the tactile resistance between the piston 20 and the lumen 14 when the piston 20 advances therethrough. In the storage position, the piston 20 is removed to the position shown in Figure 1. To ensure that the piston does not involuntarily dislodge from the injector body or involuntarily advance within lumen 14, the free ends 23a 'and 23b' are located inside respective holes 21a, 21b (the hole 21b is not shown) formed in the injector body 12 next to its proximal end 16. When it is time to use the device, the surgeon presses on the pressure element with the thumb 24 whereby the free ends 23a ', 23b', assisted by their inclined edge faces, disengage from respective holes 21a, 21b, allowing the piston to move freely in a controlled manner through the lumen 14. The thrust of the fingers of spring 23a, 23b against the inner wall of lumen 14 provides the surgeon with continuous tactile feedback that allows the surgeon to advance the piston (and therefore the IOL) through lumen 14 in a very co precise and controlled.

With reference again to the piston / IOL hitch, it is important that the rear haptic 33b of the IOL does not interfere with the piston / optical tip hitch. In this regard, the end portion of the rear haptic is positioned rearward of the piston tip to the retainer 40 and the release of IOL 30. In a preferred embodiment, a recessed area 25 is disposed rearward of the tip 22 in the length of the piston shaft 20a (figure 2A). With the piston 20 in the prepared position seen in Figure 1, the recessed area 25 of the piston is generally aligned with the rear haptic 33b of the IOL 30 held by the retainer 40. As such, by releasing the retainer 40 from the injector body 20, the rear haptic 33b will be released from the haptic support element 44b and will fall into the recessed area 25 of the piston 20. Thus, when the piston 20 is advanced during the use of the device in surgery, the rear haptic 33b will reside in the recessed area 25 and will not become entangled or otherwise interfere with the proper engagement of the piston tip and the optic of the IOL (Figure 2B).

With reference to the front haptic 33a, it is important that the front haptic does not "squeeze" into the continuous taper injector tip 18 when the IOL 30 is pushed therethrough. One way to prevent this from happening is to straighten the front haptic 33a inside the tip 18. To carry it out, a haptic traction device 80 is provided which is the subject of US Patent No. 6,491,697 of the same assignee . The haptic traction device 80 has an axis 82, tip 84 and traction element with the finger 86. Together, the tip 84 is inserted into the tip of the injector with the traction element with the finger positioned outwardly next to it. (see figure 4). Tip 84 is configured with a lip to engage the front haptic 33a (see Figure 2A). At the time of using the device 10, the haptic traction device 80 is grasped on the traction element with the finger 86 and moves away from the injector body 12 in the direction of the arrow in Figure 6, engaging and straightening it. the front haptic 33a inside the tip 18, whereby the haptic traction device 80 can be discarded.

To ensure that the front haptic 33a engages with the tip of the haptic traction device 84 when the IOL retainer 40 is removed from the injector body 12, the tip of the haptic traction device 84 is placed on the tip of the injector 18 in alignment with the front haptic 33a when secured with the haptic support member 44a of the IOL retainer 40. Thus, by releasing the IOL retainer 40 from the injector body 12, the front haptic 33a is released from the support member of Haptic 44a and falls into position on the tip of haptic traction device 84 as shown in Figure 2A.

The loaded condition and the IOP dispensing sequence

When it is time to use the injector device 10, the surgeon selects the injector device with the appropriate IOL preloaded therein, as described above. The outer packaging is removed in a sterile place in the operating room. To load the IOL in the administration position seen in Figure 2A, the nurse or surgeon grabs and removes the IOL retainer 40 from the injector body 12. This is done by manually grasping the finger grip 41 and moving the retainer away. 40 of the injector body 12, as shown by the directional arrow 1 in Figure 4. As described above, the separation finger 50 acts to prevent the IOL 30 from rising together with the retainer 40. Thus, the optics of the IOL 31 will be released from the IOL optical support element 42a, 42b and the front and rear haptics 33a, 33b will be released from their respective haptic support elements 44a, 44b. Once the retainer 40 has been completely separated from the injector body 12, it can be discarded or recycled. With the IOL 30 thus completely released from the retainer 40, the IOL 31 optics rests in the loading bay area 27 of the injector lumen 14 with the front haptic 33a engaging the tip of the haptic traction device 84 and the rear haptic 33b located in the recessed area 25 next to the piston tip 22 as described above. In this regard, it is indicated that, upon release of IOL 30 from retainer 40, IOL 30 will fall slightly to lumen 14. This is best seen in Figures 3C and 3D where in, Figure 3C, IOL 30 is attached by the retainer 40 with the periphery of the optic 31a located slightly above the groove 14a formed and extending longitudinally along the inner wall of the lumen 14. Upon removal of the retainer 40 and the release of the IOL 30 from it , the periphery of the optic 31a aligns with the groove 14a along one side of the lumen. Then, when moving the compressor drawer 60 to the fully closed position (see directional arrow 2 in figure 4), the opposite edge of the periphery of the optic 31a is engaged in the slot 60a of the drawer 60 (see also figure 8). Thus, the lumen 14 together with the lumen groove 14a, the drawer groove 60a, and the upper wall 60b of the drawer compresses and encloses the IOL optic 31 inside the lumen 14. The placement of the periphery of the optic 31a within opposite grooves 14a and 60a ensures a flat dispensing of IOL 30 through lumen 14 and exit through tip 18. This flat dispensing form of IOL is described in more detail in US Patent No. 6,491,697 cited above, from the same assignee.

Before removing the retainer 40, closing the drawer 60 and compressing the IOL 30 into the injector body, it may be desirable to apply viscoelastic to the area surrounding the IOL 30 to facilitate dispensing of the IOL through the injector body. This is a common practice in the industry, and the amount and position of the viscoelastic application varies according to the instructions provided with the device, as well as the surgeon's wishes. In any case, in a preferred embodiment, one or more viscoelastic access holes are arranged in the injector device to facilitate the application of the viscoelastic in the IOL area. Thus, one or more access holes P1 can be arranged in the form of a through hole in the separation finger 50. The access hole P1 is accessible by an injection nozzle inserted in the viscoelastic hole P1. Alternatively or in addition to the access holes P1, one or more access holes P2 can be arranged in any desired position through the wall of the tip 18 (see Figures 3B-D). Alternatively or in addition to the viscoelastic holes P1 and P2, viscoelastic can be applied in the loading bay 27 in the holes P3 and P4 defined between the optics and the retaining haptic support elements 40 (see Figure 3A). Once the viscoelastic has been applied as desired, the retainer 40 is removed and the compressor drawer 60 is moved to the fully closed position whereby the IOL 31 optic is compressed and prepared for placement through a small incision formed in one eye. The fully closed position of the drawer 60 and the compressed position of the IOL 30 are shown in Figure 3D, as described above. The drawer 60 is slidably received between cooperatively formed drawer slides 61a, 61b that extend laterally to the injector body 12 next to the hole 26. Seals or other elements (not shown) can be arranged on the front surfaces of the slides of drawer 61a, 61b and drawer 60 to help keep drawer 60 in the fully open and intermediate positions, respectively. Such drawer fasteners are especially useful for preventing unintentional sliding and / or complete closure of the drawer 60 before the necessary time (for example, during storage or removal of the device 10 from its associated package).

Then, the haptic traction device 80 moves away from the injector body 12 (Figure 6) and the front haptic 33a straightens into the tip of the injector 18. If desired or accurate, the piston 20 can be advanced slightly before removing the haptic traction device 80. The surgeon inserts the tip of the injector 18a into the incision made in the eye and begins to advance the piston 20. When the piston 20 advances, the piston tip 22 engages the periphery of the optic 31a and pushes the IOL 30 forward, leaving the rear haptic 33b located in the recess 25 of the piston 20. Upon continued advance of the piston 20, the IOL 30 is pushed through the tip of the injector 18a and finally ejected from it and at eye (figure 7). A helical spring 27 may be arranged around the distal length of the piston shaft 20a to provide greater thrust in the reverse direction when the piston reaches the fully advanced position. This occurs when the spring 27 is compressed between the leading edge 20b 'of the proximal length 20b of the shaft and the radial extension 12a of the injector body 12 (see Figures 1 and 6). This helps the surgeon maintain exact control of the piston advance (and therefore of the IOL) and allows automatic retraction of the piston by relieving the thrust pressure exerted against the piston pressure element with the thumb 24. This is useful for easily executing a second piston stroke in order to engage and manipulate the rear haptic in position in the eye. This characteristic, together with the bifurcated tip of the piston 22, allows control and manipulation of the IOL with the piston tip in situ more accurate than would be possible with an injector device that did not have these characteristics.

The partially preloaded condition

in an alternative embodiment of the invention, instead of being completely preloaded as described

previously, the injector device is "partially preloaded", which means that IOL 30 and retainer 40 are

coupled together as shown in Figures 5A-C and sealed in a package 51 as shown in Figure 10 which is separated from another package in which the injector body 12 is supplied. The package 51 can be thermoformed including a cavity 51a in the general form of the retainer 40 and the IOL 30 coupled together. A flexible cover sheet 51b is sealed around the perimeter of the cavity 51a to seal the retainer 40 and the IOL 30 in the package 51. This embodiment allows the doctor to choose a package that has a specific model of retainer and IOL. This is then combined with the separately packaged injector body 12 which is common to all IOL models. Thus, in this alternative embodiment, the doctor or nurse removes the cover 51b to remove the retainer 40 and the IOL 30. The injector body 12 is removed from its respective container, and the retainer 40 having an IOL 30 already coupled to he joins the injector body 12 at the time of surgery. It will be appreciated that the direct handling and handling of the IOL 30 itself is not necessary in the preloaded or partially preloaded embodiments of the invention.

In the partially preloaded embodiment, the injector body 12 is supplied with the compressor drawer 60 in the fully open position seen in Figure 3B such that the separating finger 50 is located laterally adjacent to the hole 26 (or the separation finger is not yet attached to the injector body 12 where the separation finger is a separate component). The nurse or doctor then opens the package that houses the body of the insertion device and proceeds to couple the retainer and IOL to the injector body through the hole 26. Once the retainer 40 and the IOL 30 are coupled to the body of the insertion device 12, the separation finger 50 is inserted between the wall surface 46 of the retainer and the optic 31 of the IOL. This can be done by advancing the compressor drawer 60 to the intermediate position shown in Figures 1, 3A and 3C. In the embodiment shown in Figure 3E, this is accomplished by joining the separating finger 50 and the clip 50a combined to the injector body 12 in front of the drawer 60.

Figures 13A-16A illustrate another preferred embodiment of the invention: to facilitate understanding, the reference numbers used in the embodiments of the preceding figures 1-12 will be used for similar parts of Figures 13A16B, increased by 100. Unless otherwise indicated, the description of other embodiments also applies to this embodiment.

With reference to Figures 13A-13F, it is appreciated that a retainer 140 for detachably holding an IOL includes one or more, but preferably two optical support elements 142a and 142b each having a groove 142a ', 142b' or other characteristic for detachably supporting the optics of IOL 131 at its periphery 131a. The grooves 142a ', 142b' are spaced above the support surface 146 such that the optics 131 is equally spaced above the support surface 146. The distance between the support surface and the optics is selected to extend the separating finger 150 of the compressor drawer 160 in between as explained more fully below. The upper surfaces 142a "and 142b" are tilted downward to provide an "entry" that facilitates the placement of the periphery of the optics 131a in slots 142a ', 142b'.

Alternatively, or in addition to the optical support elements, one or more, but preferably two haptic support elements 144a and 144b are disposed in the retainer 140, each including a groove 144a ', 144b' or other feature for releasably supporting one or more, but preferably two haptics 133a and 133b that join and extend from the optic 131. The retainer 140 holds at least the optic of the IOL 131 in the unstressed state. It is also preferable that the retainer 140 holds the IOP haptics at the correct vault angle (i.e., the angle at which they normally extend from the periphery of the IOL optic). It is even more preferable that the haptic support elements hold loop haptics at the correct lens diameter d1 (see Figure 13G). In Figures 13A-D it is seen that the haptic support elements 144a, 144b retain the haptics 144a ', 144b' along their curved outer edges, respectively. This ensures that the diameter of the lens d1, which is designed and established in manufacturing, does not increase or deviate from the specification during storage of the IOL and retainer.

In addition to maintaining the lens diameter as described above, it is preferred that the optics 131 remain stationary with respect to the retainer 140 in order to avoid damaging the IOL and ensure proper alignment of the optics 131 with the hole 126 of the injector body 112 when the seal is attached to the injector body. As best seen in Figures 13A, B and D, a slot 143 is arranged in at least one optical support element 142b where a respective haptic 133b extends alongside the optics 131. The slot 143 serves to prevent translation lateral or left rotation of IOL 130 (as seen in Figures 13A and B) while it is coupled to retainer 140, in particular during transport and storage. If the IOL 130 began to move or turn to the left, the haptic 133b would find and contact the side wall 143 'defining the groove 143 and thus preventing translation and rotation. Likewise, the translation or rotation of the IOL in a clockwise direction is avoided by the inner walls 142a ”, 142b” that the haptics will find and contact if they begin to move or move in the right direction.

With IOL 130 attached to retainer 140, the combination of retainer and IOL is prepared to bind to injector device 112; As described above in relation to previous embodiments, this can be done at the time of manufacture, at the time of use by the surgeon or nurse, or at any time in between.

The retainer 140 may further include first and second connecting legs 145a, 145b extending from opposite edges of the surface 146. The legs 145a and 145b are spaced a distance that allows extracting the retainer 140 to be attached to the device 112 as seen in the Figures 15A-15D astride the drawer slides 161a, 161b extending laterally to the injector body 112 next to the hole 126. The legs 145a, 145b may be provided with retainers 145a ', 145b' at their ends to provide a hitch snap fit between retainer 140 and drawer slides 161a, 161b, respectively. The snap-in hitch must be strong enough to prevent involuntary decoupling of the body retainer 112, although also allowing the retainer 140 to be manually decoupled without using excessive force. As best seen in Figures 15A and 16A, the first and second tabs 165a, 165b are disposed at the junctions of the drawer slides 161a, 161b and the body 112 of the device, respectively, and serve to accurately position the legs 145a, 145b and thus accurately position the retainer 140 in the body of the device 112. The retainer 140 may further include first and second flanges 147a, 147b, which rest in drawer slides 161 a, 161b when the retainer 140 is properly placed in the body 112 of the device, as described above. The tabs 147a, 147b contribute to stabilize the retainer 140 in the body 112 of the device and also help the user to pivot the retainer out of the device around the flange corners 147a ', 147b' which act as the pivot points (see also Figure 15C). In the case where the retainer 140 is to be packaged and shipped separately from the injector 112, a protective cover 200 is disposed that can be removably coupled to the retainer 140 (Figures 13E-F). The cover 200 includes a finger grip tab 204 extending from the enclosure 202 having four side walls 206a, 206b, 206c and 206d and an upper wall 206e defining a central hole 208. The opposite side walls 206b and 206d, they include a flange 206b ', 206d' next to the hole 208. The tabs 206b ', 206d' include a groove 206b ", 206d" where the first and second connecting legs 145a, 145b of the retainer 140 can slide freely, respectively. Thus, in order to initially connect the cover 200 to the retainer 140, the two parts are aligned, as seen in Figure 13D, and they move together until the surface 146 of the retainer rests on the tabs 206b ', 206d' and the seals 145a ', 145b' hook the upper wall 202e of the upper cover, as seen in Figure 13E. In the state of attachment of the retainer and the cover shown in Figure 13E, the optic of the IOL 131 remains coupled to the retainer 140. As seen in Figure 13F, the upper wall interior 206e 'may be provided with features to contribute to give slack and / or support to the IOL. For example, a circular recess 210 may be arranged that aligns with the position of the optic 131 of the IOL to ensure that there is sufficient clearance to prevent the optic of the IOL 131 from touching the inner wall 206e '. One or more projections can also be arranged as in 212 and 214 that act as auxiliary supports of the peripheral edge 13 of the optics. One or more projections 218, 220 can be provided that act as auxiliary supports for haptics 133a and 133b, respectively. At the time of surgery, the cover 200 is removed moving the retainer 140 away from the cover 200. The cover 200 can be subsequently discarded.

Before joining the seal 140 and the IOL 130 combined to the device 112, the compressor drawer 160 is placed in the open position as seen in Figures 14 and 15A. The compressor drawer 160 includes opposite side rails 161a, 161b with an elastic arm 161c extending therebetween, a pressure device with the finger 160c, an optical separation finger 150 and first and second haptic fingers 151 and 153 which generally extend parallel and spaced on both sides of the optical separation finger 150. When in the open position, the front edges of the optical and haptic separation fingers 150, 151, 153 are laterally spaced from the hole 126 as see better in Fig. 14. As best seen in Fig. 15A, the leading edge 163a of the arm 163 has a groove that engages the leading edge 161d of the shelf 161c to prevent further unintended advancement of the drawer 160 with respect to the device 112 This feature allows you to correctly position the open position of the drawer 160 when manufacturing and prevent premature advancement of the drawer during tra Support and handling. With the drawer 160 in the open position, the combined retainer and IOL can be mounted in the hole 126 by grasping the retainer 140 with the finger grip device 141 and the astride legs 145a, 145b around the drawer slides 161a, 161b as described above.

When it is time to use the device in surgery, the surgeon or nurse presses on the pressure device with the finger 160c of the drawer while also pressing up on arm 163 (for example, with the thumb) to unhook the leading edge 163a of the leading edge arm 161d of the shelf. Once this is done, the drawer 160 is advanced further towards the hole 126 of the device 112, passing the arm 163 over the shelf 161c. The advance of the drawer is continued until the separation fingers 150, 151 and 153 have extended between the IOL 130 and the surface 146 of the retainer as best seen in Figures 15B, 15D and 15E. This position will be observed by the user when the tab 160d of the drawer 160 extending vertically (see Figures 15D and 16B) contact the edge 146a of the surface 146 of the retainer (see Figure 15D).

With the separation fingers 150, 151 and 153 placed between the IOL 130 and the surface 126 of the retainer, the retainer 140 can be disengaged from the device 112 by grasping the traction element with the finger 141 and away from the device 112 as seen in the Figure 15F. It is indicated that the retainer 140 can be pushed straight (arrow in Figure 15F) or in a pivot movement (arrow in Figure 15C) with respect to the body 112 of the device. Before and / or after uncoupling the retainer 140, the surgeon may apply viscoelastic to IOL 130 through hole 126 and / or hole 150a. It will be noted that the central separation finger 150 acts to separate the optic of the IOL 131 from the retainer 140 while the separation fingers 151 and 153 act to separate the respective haptics 133a and 133b. In addition to serving to separate the IOL from the retainer, the separation fingers also help keep the IOL at least partially submerged in the viscoelastic bath applied by the surgeon. Without this assistance of the separation fingers, the IOL can “float” on top of the viscoelastic, which can be detrimental to a successful placement of the IOL. It is also indicated that the hole 150a in the optics separation finger 150 helps stabilize the optics of the IOL 31 when it is separated from the retainer 140. To explain, when the retainer 140 is disengaged from the injector body 112, the two haptics are they can release their respective haptic support elements at different times by causing the optics to "swing" in the direction of the haptic when it is released from its associated support element. The hole 150a thus helps prevent the optics from tilting, providing a 360 ° surface against which the peripheral edge of 360 ° 131a can press during the separation process. The hole 150a 'may also be provided with an inclined entry edge 150a' (Figure 16C) to improve this stabilizing effect.

Once the retainer 140 is disengaged from the device, the IOL 130 is placed in the hole 126 in the manner described above (see Figure 2A) and is prepared for folding and placement in one eye. The user thus continues to advance the drawer 160 to the fully closed position by pressing inward on the pressure device with the finger 160c of the drawer. It is indicated that a side hole 5 is provided in the body 112 in front of the drawer 60 (see Figures 14 and 15F). Hole 155 so that the free end of the rear haptic 133b can pass through it if the closure of the drawer 160 begins to catch this haptic. A finger grip device 170 can be arranged in the device 112 in front of the drawer 160 to help the user hold the device while closing the drawer. The fully closed position of drawer 160 is shown in Figure 16A. In this position, the separation fingers 150, 151 and 153 are now located laterally to the device 112 on the flange 170. The IOL 130 is compressed and prepared for dispensing.

Then, the haptic traction device 180 moves away from the injector body 112 (see Figure 6) and the front haptic 133a straightens into the tip of the injector 118. As seen in Figure 17, the traction device of Haptic 180 includes a traction element with the finger 186 and an axis 182 and tip 184. When assembling, the tip 184 is inserted into the tip of the injector with the traction element with the finger located adjacently adjacent (see figure 14). Tip 184 is configured with a lip to engage the front haptic 133a (see Figures 14 and 15E). At the time of using the device 110, the haptic traction device 180 is grasped on the traction element with the finger 186 and moves away from the injector body 112, thereby engaging and straightening the front haptic 133a inside the tip 118, by what haptic traction device 180 can be discarded.

To ensure that the front haptic 133a engages with the tip of the haptic traction device 184 when the IOL retainer 140 is removed from the injector body 12, the tip of the haptic traction device 184 is placed on the tip of the injector 118 in alignment with the front haptic 133a when it is held by the haptic support element 144a of the IOL retainer 140. Thus, by separating the IOL retainer 140 from the injector body 112, the front haptic 133a is released from the support member of haptic 144a and falls into position on the tip of the haptic traction device 184. A positioning bump 183 has been formed on the traction element with the finger 186 and contacts the tip 118 when the axis of the haptic traction device 182 is completely inserted in the tip of the insertion device 118. The protuberance 183 substantially inhibits the lateral movement of the axis 182 inside the tip 118 and therefore ensures the proper and stable alignment of the tip of the haptic traction device 184 with the retainer 140 and the front haptic 133a maintained by it.

If desired or necessary, the piston 120 can be advanced slightly before removing the haptic traction device 180. The surgeon inserts the tip of the injector 118a into the incision made in the eye and begins to advance the piston 120. When it advances the piston 120, the piston tip 122 engages the periphery of the optics 131a and pushes the IOL 130 forward, placing the rear haptic 133b in the recess 125a of the piston 120. It is indicated that the piston 120 may also include a recess 125b opposite of recess 125a (see Figure 18). The second recess 125b is provided so that, if the rear haptic 133b does not line up and is placed in the first recess 125a, the rear haptic is instead placed in the second recess 125b and thus has clearance to move forward and out of the lumen Of the device. Upon continued advance of the piston 120, the IOL 130 is pushed through the tip of the injector 118a and is finally ejected from it to the eye.

A pair of springs 220a, 220b having respective tips 220a ', 220b' can be arranged on the piston shaft. The injector body 112 may also be provided with a pair of through holes 112a, 112b through which the tips for establishing the initial position (transport) of the piston 120 may be. These characteristics are more fully described in our WO 2005/065 589 in process, of date of subsequent publication (application serial number 10 / 744,981 filed on 12/22/03). The pressure of the piston causes the tips to be removed from the holes 112a, 112b and then pushed against the inside of the body 112. This helps the surgeon maintain exact control of the advance of the piston (and therefore of the IOL). A spring (not shown) can also be arranged around the piston shaft 120 to allow automatic retraction of the piston by relieving the thrust pressure exerted against the piston pressure element with the thumb 24 as described above.

Claims (11)

one.

An IOL injector device comprising:

a) an injector body (12); b) a retainer (40) adapted to detachably maintain an IOL (30) in a non-stressed state said retainer and the IOL is extractablely connected to said injector body, and c) a separation element located between the retainer and the IOL , said separation element being able to operate to prevent the IOL from being released with the retainer when the retainer is removed from the injector body; whereby, after removing said retainer from said injector body by separating the retainer from the injector body, said IOL is released from said retainer, separated from it by the separation element, and placed within said ready injector body for dispensing therethrough and into an eye, said placement of the IOL within said injector body in a state not subjected to stress.

2.

 The IOL injector device of claim 1 wherein said injector device including said retainer and said IOL connected thereto are sealed in a single package (11).

3.

 A method for loading an IOL into an internal passage of an injector body comprising the steps of: a) providing a retainer adapted to detachably maintain an IOL in a non-stressed state; b) removably attaching said retainer to said injector body; c) placing a separation element between the retainer and the IOL, said separation element being able to operate to prevent the IOL from being released with the retainer when the retainer is removed from the injector body; and d) removing said retainer from said injector body, separating the retainer from the injector body, whereby said IOL is released from said retainer, separated from it by the separation element and placed in said open passage in a non-state subjected to effort.

Four.

 The method of claim 3, and further comprises a step of packaging said injector body, said retainer and said IOL together while said retainer is attached to said injector body and said IOL is detachably attached to said retainer.

5.

 The method of claim 3, and further comprising the steps of:

e) providing a compressor and compressing said IOL in said open passage; and f) providing a piston having a piston tip in said open passage and advancing said piston therethrough, thereby pushing said IOL with said piston tip to eject said IOL from said injector body.

6.

 The method of claim 5 and further comprising a step of applying a viscoelastic to one or bos of said IOL and said open passage before said compression step.

7.

 The method of claim 3, and further comprising the steps of:

e) providing a piston having a piston tip in said open passage to advance said IOL through said open passage; f) provide the IOL in such a way that it has an optics and a rear haptic that extends from said optics; and g) placing said retainer relatively, with said IOL detachably held by it, and said piston in said open passage such that, upon removal of said retainer and release of said IOL at said open passage, said rear haptic is positioned towards behind said piston such that, when advancing said piston through said open passage, said piston tip engages said IOL optics without contacting said rear haptic.

8.

 The method of claim 3, and further comprising steps of:

e) provide the IOL in such a way that it has an optics and a front haptic that extends from said optics; f) inserting a haptic traction device having a haptic traction device tip in said open passage, the haptic traction device being adapted to engage and straighten said front haptic inside said distal end when removing said traction device of haptic of said injector body; and g) relatively placing said retainer with said IOL detachably held by it and said haptic traction device in said open passage such that, upon removal of said retainer and release of said IOL at said open passage, said front haptic is located next to said tip of haptic traction device.

9.

 The method of claim 3, and further comprising the steps of:

e) provide the IOL in such a way that it has a front and rear haptics that extend from said optics; f) providing a piston having a piston tip in said open passage to advance said IOL through said open passage g) inserting a haptic traction device having a haptic traction device tip in said open passage, being adapted the haptic traction device for engaging and removing said at least single haptic from said distal end when removing said haptic traction device from said injector body; and h) relatively placing said retainer with said IOL detachably held therein, said piston, and said haptic traction device in said open passage such that, upon removal of said retainer and release of said IOL to said open passage, said rear haptic is located on the side of said piston tip in front of said optics, and said front haptic is positioned next to said haptic traction device tip.

10.

 The method of claim 3, and further comprising the steps of:

e) providing a mobile compressor between an open position and a closed position with respect to said injector body, said compressor being in said open position when said retainer is attached to said injector body and said IOL is maintained by said retainer, and f) after the step of removing said retainer from said injector body, moving said compressor to said closed position and thereby compressing said IOL in said open passage.

eleven.

 The method of claim 10, wherein said compressor and said separation element are connected and move together so that the step of moving said compressor to said closed position causes said stop element to move away from said injector body.